Do not administer as bolus inj. Increased risk of PML especially w/ presence of anti-JCV Ab, >2 yr treatment duration & receiving immunosuppressant prior to therapy. Permanently discontinue if PML, opportunistic infections, significant liver injury or hypersensitivity develop. Perform testing for serum anti-JCV Ab prior to initiating therapy or in patients receiving Tysabri w/ an unknown Ab status. Re-test anti-JCV Ab negative patients every 6 mth. Do not perform anti-JCV Ab testing w/in 2 wk of plasmapheresis, or w/in 6 mth of IVIg. Recent MRI should be available before initiation of treatment, & repeated at least yrly. Patients switching from DMTs w/ an immunosuppressant effect should be frequently monitored. Immune reconstitution inflammatory syndrome (IRIS). Risk of opportunistic infections in patients w/ Crohn's disease who were immunocompromised or where significant co-morbidity existed; encephalitis & meningitis development. Refer patients w/ eye symptoms eg, decreased visual acuity, redness & eye pain for retinal screening for acute retinal necrosis. Perform CBC (including lymphocytes) prior to initiation of therapy. Not recommended to initiate treatment after alemtuzumab. Permanently discontinue if hypersensitivity reaction occurs. Concomitant use w/ immunosuppressants. Immunogenicity. Monitor patient for an impaired liver function. Patients on controlled Na diet. May affect the ability to drive or operate machinery. Pregnancy & lactation (discontinue use). Childn & adolescents up to 18 yr. Elderly >65 yr.
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